Anorexia Nervosa (AN) is a challenging, chronic, refractory illness with the highest mortality rate of any psychiatric condition. Advances in the neuroimaging, genetics and neurobiology of AN has led to a greater understanding of its underlying pathophysiology, although few significant advances in treatment have been made in the last half-century. The central features of AN, which include an intense fear of gaining weight, a refusal to maintain a normal weight, as well as significant anxiety, anhedonia and dysphoria surrounding food, have been linked to dysfunction in key brain structures and circuits. Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the insertion of electrodes into structures believed to drive pathological behavior. The procedure is approved for the management of movement disorders, such as Parkinson's Disease, and has shown promising early results in the management of some psychiatric conditions, such as Major Depression. The purpose of this study is to explore the safety and initial efficacy of DBS, in patients with treatment resistant AN.

Quality of Life [ Time Frame: Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Health Survey Short Form (SF36), Quality of Life Scale

Estimated Enrollment:

12

Study Start Date:

July 2011

Estimated Primary Completion Date:

March 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Procedure: Deep Brain Stimulation

Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone.

Eligibility

Ages Eligible for Study:

20 Years to 60 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Female or Male patients between age 20-60

Diagnosis of Anorexia Nervosa, restricting or binge-purging subtype as defined by the Diagnostic and Statistical Manual (DSM-IVR)

Chronicity and/or Treatment Resistance as demonstrated by some or all of:

A pattern of three year's duration of relentless unresponsiveness to repeated voluntary hospitalizations, characterized by failure to complete treatment of immediate weight relapse following treatment;

pattern of increasing medical instability accompanied by refusal to participate in/lack of responsiveness to intensive expert treatment and increasing medical acuity, lasting at least two years and involving at least two episodes of involuntary feeding;

A pattern of chronic stable AN lasting at least 10 years

Able to comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

Any past or current evidence of psychosis

Active neurologic disease such as epilepsy

Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine

Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions as a result of AN or not, that will result in significant risk from a surgical procedure.

Pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476540